Conservative vs liberal fluid therapy in septic shock (CLASSIC) trial-Protocol and statistical analysis plan

MEYHOFF, T.S., P.B. HJORTRUP, M.H. MOLLER, J. WETTERSLEV, T. LANGE, M.B.N KJR, A.B. JONSSON, C.J.S HJORTSO, M. CRONHJORT, J.H. LAAKE, S.M. JAKOB, M. NALOS, V. PETTIL, I. VAN DER HORST, M. OSTERMANN, P.. MOUNCEY, K. ROWAN, M. CECCONI, R. FERRER, M.L.N.G. MALBRAIN, C. AHLSTEDT, S. HOFFMANN, M.H. BESTLE, L. NEBRICH, L. RUSSELL, M. VANG, M.L. RASMUSSEN, C. SOLLING, B.S. RASMUSSEN, A.C. BROCHNER and A. PERNER. Conservative vs liberal fluid therapy in septic shock (CLASSIC) trial-Protocol and statistical analysis plan. Acta Anaesthesiologica Scandinavica. HOBOKEN: WILEY, 2019, vol. 63, No 9, p. 1262-1271. ISSN 0001-5172. Available from: https://dx.doi.org/10.1111/aas.13434.

Basic information

• Original name: Conservative vs liberal fluid therapy in septic shock (CLASSIC) trial-Protocol and statistical analysis plan
• Authors: MEYHOFF, T.S. (guarantor), P.B. HJORTRUP, M.H. MOLLER, J. WETTERSLEV, T. LANGE, M.B.N KJR, A.B. JONSSON, C.J.S HJORTSO, M. CRONHJORT, J.H. LAAKE, S.M. JAKOB, M. NALOS, V. PETTIL, I. VAN DER HORST, M. OSTERMANN, P.. MOUNCEY, K. ROWAN, M. CECCONI, R. FERRER, M.L.N.G. MALBRAIN, C. AHLSTEDT, S. HOFFMANN, M.H. BESTLE, L. NEBRICH, L. RUSSELL, M. VANG, M.L. RASMUSSEN, C. SOLLING, B.S. RASMUSSEN, A.C. BROCHNER and A. PERNER.
• Edition: Acta Anaesthesiologica Scandinavica, HOBOKEN, WILEY, 2019, 0001-5172.

Other information

• Original language: English
• Type of outcome: Article in a journal
• Field of Study: 30230 Other clinical medicine subjects
• Country of publisher: United States of America
• Confidentiality degree: is not subject to a state or trade secret
• WWW: CLASSIC
• Impact factor: Impact factor: 2.050
• RIV identification code: RIV/00216224:14110/19:00124330
• Organization unit: Faculty of Medicine
• Doi: http://dx.doi.org/10.1111/aas.13434
• UT WoS: 000477274600001
• Keywords (in Czech): INTENSIVE;CARESEPSIS;PROTOCOL; MISSING DATA; RESUSCITATION; MANAGEMENT; MORTALITY; VOLUMES; ADULTS
• Keywords in English: INTENSIVE;CARESEPSIS;PROTOCOL; MISSING DATA; RESUSCITATION; MANAGEMENT; MORTALITY; VOLUMES; ADULTS
• Tags: Excelence Science, INT, MU, user

Abstract

Introduction Intravenous (IV) fluid is a key intervention in the management of septic shock. The benefits and harms of lower versus higher fluid volumes are unknown and thus clinical equipoise exists. We describe the protocol and detailed statistical analysis plan for the conservative versus liberal approach to fluid therapy of septic shock in the Intensive Care (CLASSIC) trial. The aim of the CLASSIC trial is to assess benefits and harms of IV fluid restriction versus standard care in adult intensive care unit (ICU) patients with septic shock. Methods CLASSIC trial is an investigator-initiated, international, randomised, stratified, and analyst-blinded trial. We will allocate 1554 adult patients with septic shock, who are planned to be or are admitted to an ICU, to IV fluid restriction versus standard care. The primary outcome is mortality at day 90. Secondary outcomes are serious adverse events (SAEs), serious adverse reactions (SARs), days alive at day 90 without life support, days alive and out of the hospital at day 90 and mortality, health-related quality of life (HRQoL), and cognitive function at 1 year. We will conduct the statistical analyses according to a pre-defined statistical analysis plan, including three interim analyses. For the primary analysis, we will use logistic regression adjusted for the stratification variables comparing the two interventions in the intention-to-treat (ITT) population. Discussion The CLASSIC trial results will provide important evidence to guide clinicians' choice regarding the IV fluid therapy in adults with septic shock.

Links

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